Moderna Begins Submission Process for FDA Approval for COVID-19 Vaccine

Moderna announced it is seeking full FDA approval for its COVID-19 vaccine mRNA-1273.

In a statement released on Tuesday, the company said it has initiated the rolling submission process for the biologics license application (BLA) and will continue to submit data from its phase 3 study to support the application for use of the vaccine in individuals 18 years and older. Once the rolling BLA submission process is completed, the FDA will notify Moderna when it is formally accepted for review.¹

A Timeline of Key Regulatory and Clinical Updates

• On December 18, 2020, the FDA authorized Moderna’s vaccine for emergency use based on a data analysis from the phase 3 COVE study and a primary efficacy analysis conducted on 196 cases which indicated a vaccine efficacy rate of 94.1%.
• In February 2021, Moderna completes manufacturing of clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351, against the SARS-CoV-2 variant known as B.1.351 and has shipped doses to the National Institutes of Health for the phase 1 clinical trial.²
• In an amendment to the ongoing phase 2 clinical study, the first participants were dosed with the company’s modified COVID-19 vaccines in March to evaluate booster vaccine candidates.³
• On April 6, data published in The New England Journal of Medicine demonstrated antibody persistence through 6 months following the second dose of the vaccine.⁴
• In May, Moderna reported initial data from its phase 2 study showing that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a booster increased neutralizing antibody titer responses against SARS-CoV-2 and variants B.1.351 and P.1.5
• On May 25, Moderna released data from its phase 2/3 TeenCOVE study, demonstrating the safety and efficacy of mRNA-1273 in adolescents aged 12 to <18 years. Moderna announced plans to seek authorization for this age group in June.

Pfizer is applying for full approval of its COVID-19 vaccine, BNT162b2, for use in individuals aged 17 years and older.

References

1. Moderna Announces Initiation of Rolling Submission of Biologics License Application (BLA) with U.S. FDA for the Moderna COVID-19 Vaccine. News Release. Moderna; June 1, 2021. Accessed June 1, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-initiation-rolling-submission-biologics
2. Moderna Announces it has Shipped Variant-Specific Vaccine Candidate, mRNA-1273.351, to NIH for Clinical Study. News Release. Moderna; February 24, 2021. Accessed June 1, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-it-has-shipped-variant-specific-vaccine
3. Moderna Announces First Participants Dosed in Study Evaluating COVID-19 Booster Vaccine Candidates. News Release. Moderna; March 10, 2021. Accessed June 1, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-first-participants-dosed-study-evaluating
4. Doria-Rose N, Suthar MS, Makowski M, et al. Antibody persistence through 6 months after the second dose of mRNA-1273 vaccine for COVID-19. The New England Journal of Medicine. April 6, 2021. Doi: 10.1056/NEJMc2103916
5. Moderna Announces Positive Initial Booster Data Against SARS-CoV-2 Variants of Concern. News Release. Moderna; May 5, 2021. Accessed June 1, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-initial-booster-data-against-sars-cov